QA Validation technician and CSV

We are looking for a new “QA/CSV Specialist” who will offer service to a multinational pharmaceutical company.

🌐 Sant Cugat (Barcelona)


  • Support the team in order to ensure that processes within computerized systems (e.g. ERP (SAP), Trackwise)
    are implemented and used in a compliant manner (GxP) following internal and external regulations.
  • Approval of System Life Cycle documentation in compliance to the respective validation methodology.
  • Support deployment according to the BI internal standard method.
  • Ensure audit readiness and supports regional audits of systems in scope of the position.
  • Regional interactions with all relevant business units (i.e. Production sites and commercial sites) and Global Functions, as well as cross functional project teams.
  • Support the handover of quality tasks to the run organization.
  • Support that further externals which supporting other internal department(s) are working under the agreed methodology.
  • Guides and defines work packages for external support and monitors the quality of deliverables.
  • Partner with and educate business stakeholders and cross functional project teams through coaching and education regarding the need for compliance with regulations and quality management processes.
  • Manage existing/additional SOPs where applicable.


  • Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise.
  • Knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems –
    including external regulations e.g. EU-GMP Guideline, Annex 11, 21 CFR Part 11, Data Integrity requirements and internal regulations.
  • Speak-up mentality/ ability to challenge and make judgment calls with Senior Management.
  • Ability to prioritize and to effectively manage multiple tasks at the same time, quickly respond to changing internal and external requirements.
  • Respect and understanding of cultural diversities across the area of responsibility.
  • Fluent in English.


  • From monday to friday: 08am to 5pm / 09am to 6pm (flexible)
  • During COVID – Full time remote.
  • After COVID – Mandatory minimum 3 days of office work.


  • Salary package based on your profile.
  • Food expenses and Ticket restaurant included in-office hours.
  • Flexible compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check.
  • Discounts on physiotherapy center and gym network.
  • Training catalogue.

Our goal is that you are well in every way!

Are you interested?
Apply for information.


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